Technical differences

For the two pronounced phases of drug manufacturing, the technical differences for the use of process analytics between the chemical and pharmaceutical industries are more pronounced in the manufacturing of the formulated drug product than in the chemical synthesis and purification of the API. 

The manufacturing of the API is in principle a synthesis of fine chemicals with high quality requirements for the final product and a tight external regulatory framework. In API manufacturing, the process steps, physical and chemical characteristics of the sample and equipment are very similar to the chemical industries  

Many technical solutions developed for process analytics in the chemical industry consequently also apply in the pharmaceutical industry. Analyzer systems and implementation principles are essentially the same in both industries (see Chapter 15). 

A short summary of conceptual technical differences with respect to process analytics between the chemical and pharmaceutical industry is listed in Table 2.2. 

Process type Continuous and batch Batch, (some continuous processing efforts underway) 

Many technical solutions developed for PA in the chemical industry consequently also apply to the pharmaceutical industry. Analyzer systems and implementation principles are essentially the same in both industries. Nevertheless, there are two distinct technical differences even in API manufacturing that make PA in the pharmaceutical industry standout the absence of continuous manufacturing processes, and the well-established work process for testing including a relative abundance of quality control laboratory resources. 

Most API processes are run, in all steps, as batch processes for a number of reasons, among them the fact that the typical development of an API process with small quantities is done as a batch process (development history). Also it is straightforward to define a subset of material as a batch for regulatory and release purposes. 

The relatively extensive availability of laboratory resources for quality control is mostly a reaction to the regulatory framework of product release criteria testing. The existence of quality control laboratories in most API manufacturing sites then leads to the development of in-process tests with an off-line laboratory method. 

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The classification of motor oils has not been completed in the ISO standard because the technical differences between motors in different parts of the world, particularly Europe and the United States, make the implementation of a single system of classification and specifications very difficult. In practice, different systems coming from national or international organizations are used. The best known is the SAE viscosity classification from the Society of Automotive Engineers, developed in the United States. 

A technical difference from other Gaussian wavepacket based methods is that the local hamionic approximation has not been used to evaluate any integrals, but instead Maiti nez et al. use what they term a saddle-point approximation. This uses the localization of the functions to evaluate the integrals by... 

Noise. Technical differences exist between personal noise dosimeters and high accuracy sound level meters and these may alter the usual preference for personal monitors. But it is exposure to noise rather than general room noise that must be estimated for comparison with noise exposure criteria, the logarithmic expression and alternative means of summation (3 vs 5 db doubling) compHcate statistics. Exposure criteria for both dose and peak exposure must be evaluated, and space and time variabiUty of noise intensity can be immense. 

The main technical difference between Hquid and gas pipeline transport is the compressibiUty of the fluid being moved and the use of pumps, rather than compressors, to supply the pressure needed for transport. The primary use for Hquids pipelines is the transport of cmde oil and petroleum products. 

The technical differences between site problems at RCRA facilities and CERCLA sites sometimes may be difficult to distinguish, owing to similarities in present or past uses of the site, in hydrogeologic setting, and/or in the types of substances disposed, spilled, or otherwise managed at the site. Consequently, many technical aspects of the study and remediation of releases of hazardous wastes and constituents from RCRA facilities often will closely parallel those at Superfund sites, and cleanups under both statutes must achieve similar goals for protection of public health and the environment. Additionally, activities which would be termed removal actions or expedited response actions under CERCLA may be undertaken by owners and operators under RCRA. In the RCRA context, such actions are termed interim measures, as will be discussed in subsequent chapters. 

The pH of solutions is generally measured with a pH meter, an instrument that in a single, simple operation measures and yields the pH value of any water solution, thus making unnecessary any further measurements or calculations. There are many technically different pH meters, some large, used mainly in laboratories, others portable, easily taken out for field measurements. The pH can, however, also be measured using substances known as indicators, which exhibit different colors, shades, or hues at different pH values. Litmus, for example, is an indicator that exhibits shades of red in acid solutions, that is, in solutions having pH values between 7 and 1, and shades of blue when in alkaline solutions with pH values between 7 and 14. 

Other high-pressure stopped-flow/CL systems are based on special mixing modes, the main technical difference of which is that the CL observation cell... 

Cross comparisons Ability to identify common biomarkers linked with toxicity across systems High difficulty in comparisons due to multiple factors influencing response, as well as technical differences... 

In the case of the high temperature SOFC discussed below the principles outlined above equally apply. The technical differences are that the cell runs typically on hydrocarbon fuels (e.g. natural or coal-gas) and that the electrolyte is an oxygen ion conductor rather than a proton conductor. The complex fuel molecules, in the presence of the water molecule and at the high operating... 

The ways in which Environmental Quality and Human Health Standards are derived, and the frameworks within which they are used, differ between countries and regions, with standards derived, expressed, monitored, and implemented in different ways. To some extent, this diversity reflects genuine technical differences that must be taken into account in the development of standards for different compartments (e.g., water or soil) or for different receptors (e.g., humans, livestock, or flora and fauna). However, much standard setting has been developed in a piecemeal fashion with little consistency between schemes in the levels of protection sought, the selection of chemicals for which standards may be needed, the methods used to derive them, or the methods used to monitor compliance. These differences can lead to the implementation of substantially different values from the same empirical data, which must mean that their application is either over- or underprotective in at least some situations. 

A key technical difference between the two approaches is that thermal cracking of hydrocarbons to ethylene is usually performed at temperatures in excess of 800 C, whereas catalytic processes occur generally below 550°C. 

With respect to technical differences, it should be emphasized that, for metabolomic analyses, there is no single analytical technique that allows determination of all low-molecular-weight compounds, unlike genomic and proteomic analyses. In metabolomics, various complementary analytical techniques are often used in combination with advanced bioinformatics tools for analysis of large data sets. 

In spite of technical differences, HOHAHA and HEHAHA experiments also share a number of potential practical problems, for example, phase anomalies in the spectra, water suppression, and sample heating. The discussion in this section will focus on examples of HOHAHA experiments, but special features that are characteristic for HEHAHA experiments will also be pointed out. For simplicity, only two-dimensional Hartmann-Hahn experiments are considered here, but the extension of the discussed principles to hybrid or multidimensional experiments (see Section XIII) is generally straightforward. 

The terms "gas and vapor are often used interchangeably, but there is a technical difference between them that you are now in a position to understand. A vapor is a gaseous species below its critical temperature, and a gas is a species above its critical temperature at a pressure low enough tor the species to be more like a vapor than a liquid (i.e., a density closer to 1 g/L than 1000 g/L). You can condense a vapor by compressing it isothermally, but while you can make a gas denser and denser by compressing it isothermally you will never achieve a separation into two phases. Substances at temperatures above Tc and pressures above Pc are referred to as supercritical fluids. 

While it s not critical for you to know the technical difference between a symptom and a sign, it is helpful to know the terms used to describe common symptoms and signs of disease. If you suspect your plant is diseased, study its symptoms, and then review the symptom descriptions listed on the following pages. 

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